Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort

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Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort

MYLES, Paul S, et al. & StEP–COMPAC Group


Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials.

MYLES, Paul S, et al . & StEP–COMPAC Group. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort.

British Journal of Anaesthesia , 2018, vol. 120, no. 4, p. 705-711

DOI : 10.1016/j.bja.2017.12.037 PMID : 29576111

Available at:

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Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: patient comfort

P. S. Myles


* , O. Boney


, M. Botti


, A. M. Cyna


, T. J. Gan


, M. P. Jensen


, H. Kehlet


, A. Kurz


, G. S. De Oliveira Jr.


, P. Peyton


, D. I. Sessler


, M. R. Tram er


, C. L. Wu


and the StEP e COMPAC Group


Department of Anaesthesia and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia,


Surgical Outcomes Research Centre, University College Hospital, London, UK,


School of Nursing and Midwifery, Deakin University, Geelong, Australia,


Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia,


Department of Anaesthesia and Pain Management, Nepean Hospital, University of Sydney, Sydney, Australia,


Department of Anesthesiology, Stony Brook University, Stony Brook, NY, USA,


Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA,


Section for Surgical Pathophysiology, Rigshospitalet, Copenhagen,



Department of Anesthesiology, Cleveland Clinic, Cleveland, OH, USA,


Department of Anesthesiology, Center for Healthcare Studies, Institute for Public Health and Medicine, Northwestern University, Chicago, IL, USA,


Anaesthesia, Perioperative and Pain Medicine Unit, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia,


Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA,


Department of Anaesthesiology, Geneva University Hospitals, Geneva, Switzerland,


Department of Anesthesiology, The Johns Hopkins Hospital, Baltimore, MD, USA

*Corresponding author.

StEP Steering Committee members: Paul Myles (Australia) and Michael Grocott (UK), Co-Chairs; Bruce Biccard (South Africa), Jane Blazeby (UK), Oliver Boney (UK), Matthew Chan (Hong Kong), Elisabeth Diouf (Senegal), Lee Fleisher (USA), Cor Kalkman (The Netherlands), Andrea Kurz (USA), Ramani Moonesinghe (UK), and Duminda Wijeysundera (Canada).


Background:Maximising patient comfort during and after surgery is a primary concern of anaesthetists and other perioperative clinicians, but objective measures of what constitutes patient comfort in the perioperative period remain poorly defined. The Standardised Endpoints in Perioperative Medicine initiative was established to derive a set of standardised endpoints for use in perioperative clinical trials.

Methods:We undertook a systematic review to identify measures of patient comfort used in the anaesthetic, surgical, and other perioperative literature. A multi-round Delphi consensus process that included up to 89 clinician researchers was then used to refine a recommended list of outcome measures.

Editorial decision: December 29, 2017;Accepted:December 29, 2017

©2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

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705 doi:10.1016/j.bja.2017.12.037

Advance Access Publication Date: 2 February 2018 Review Article


Results:We identified 122 studies in a literature search, which were the basis for a preliminary list of 24 outcome measures and their definitions. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n¼22), 90% (n¼79), and 100%

(n¼13), respectively. A final list of six defined endpoints was identified: pain intensity (at rest and during movement) at 24 h postoperatively, nausea and vomiting (0e6 h, 6e24 h, and overall), one of two quality-of-recovery (QoR) scales (QoR score or QoR-15), time to gastrointestinal recovery, time to mobilisation, and sleep quality.

Conclusions:As standardised outcomes will support benchmarking and pooling (meta-analysis) of trials, one or more of these recommended endpoints should be considered for inclusion in clinical trials assessing patient comfort and pain after surgery.

Keywords:anaesthesia; clinical trials; patient-reported outcomes; surgery

Editor’s key points

Objective measures of patient comfort in the periop- erative period remain poorly defined.

A systematic literature review and Delphi consensus process were used to identify and define recommended outcome measures.

A final list of six defined endpoints was identified, including pain, postoperative nausea and vomiting, quality-of-recovery scales, gastrointestinal recovery, mobilisation, and sleep quality.

These recommended endpoints will facilitate future clinical trials assessing patient comfort and pain after surgery.

Maximising patient comfort during and after surgery is a pri- mary concern of anaesthetists and other perioperative clini- cians. However, the objective measures of patient comfort in the perioperative period remain poorly defined. There is a pressing need to standardise endpoints in perioperative clin- ical trials so that results can be compared across studies.1

Recent studies have suggested various measures,2e4but these recommendations were not developed in accord with current standards for the development of guidelines or consensus statements.5e7Consensus and consistency in the use of appropriate perioperative outcome measures, and their timing of assessments, would enhance the interpretation and translation of patient-centred outcomes research and improve the validity of data synthesis in meta-analysis. The use of standardised endpoints will presumably improve the ability of clinicians to compare results across trials, and for the in- vestigators to pool results from diverse studies.

The overall aim of the Standardised Endpoints in Periop- erative Medicine (StEP) initiative is to derive a set of endpoints for use in perioperative-medicine trials, based on current ev- idence, expert guidance, and international consensus.1Here, we describe the results of a systematic review and Delphi process to identify important measures of patient comfort in the perioperative setting. Patient satisfaction, quality of life, and other health-status scales are being evaluated and will be reported separately.1


We first undertook a systematic review to identify measures of patient comfort in the anaesthetic, surgical, and other peri- operative literature. A Delphi consensus process was then used to refine a recommended list of outcome measures.

We defined the perioperative period as the pre-, intra-, and post-operative phases of a patient’s surgical journey, ranging from preoperative evaluation and planning to expected full recovery. The target population was any patient having any surgical procedure requiring anaesthesia care. Patient comfort measures were defined as any subjective or objective measure of either physical, mental, or emotional comfort and well- being; discomfort or absence of comfort; or symptoms that could be described as undesirable.

Literature search

Systematic searches of MEDLINE, Embase, Web of Knowledge, and the Cochrane database were performed to identify sys- tematic reviews of trials reporting patient-comfort or pain-relief measures, and published guidelines and consensus statements or recommendations regarding the measurement of perioper- ative patient comfort or bothersome pain. This process, there- fore, collated all relevant endpoints that were used in any of the original perioperative trials. Only reviews published from January 1, 2000 onwards were included to reduce the risk of retrieving outdated or obsolete measures. Two authors (O.B. and P.S.M.) independently identified titles and abstracts of poten- tially eligible studies. Discrepancies were resolved by consul- tation between the initial two researchers. Where consensus opinion could not be reached, a third researcher was to be consulted, but adjudication was never needed. Reference lists of relevant clinical studies and review articles were explored for additional studies. A detailed description of the MEDLINE search strategy is presented in theSupplementary Table S1.

The intended population included adults (age18 yr) having any type of surgery. Exclusion criteria were any systematic review including patients<18 yr, any review where an opera- tion (using a surgical incision) was not performed (e.g. endos- copy), and any review including data from fewer than 100 patients in the analysis. Additionally, we restricted our search to the four highest impact-factor-ranked specialty journals in anaesthesia (British Journal of Anaesthesia,Anesthesiology,Anes- thesia&Analgesia, andAnaesthesia), surgery (Annals of Surgery, British Journal of Surgery,Journal of the American College of Sur- geons, andJAMA Surgery), and general medicine (New England Journal of Medicine,The Lancet,The Journal of the American Medical Association, and theBritish Medical Journal) in May 2016. Guide- lines and reviews published in other journals, but identified from hand searching of reference lists of included studies were also included if they met the other study inclusion criteria.

A total of 1044 potential studies were retrieved, of which 102 met the inclusion criteria. Hand searching of reference 706


Myleset al.


lists of included studies retrieved a further 233 potentially relevant reviews and consensus guidelines, of which 20 also met the inclusion criteria. One hundred and twenty-two studies were, therefore, included in this review (Fig. 1). The results of this systematic review informed the following Del- phi consensus process.

Delphi process

A Delphi process was used to obtain input and consensus from a group of medical and other health researchers with experi- ence in anaesthesia and perioperative-medicine trials.8,9The StEP Working Group consisted of experienced perioperative triallists and other investigators from various countries (see Supplementary Data) and was overseen by a Steering Com- mittee (see Appendix).1,10

The filtering and development of recommended perioper- ative clinical-trial endpoints were undertaken in four stages.11

Stage 1: establishing a preliminary list of trial endpoints and their definitions

Publications identified in the literature search were used to create a preliminary list of outcome measures and their defi- nitions (Fig. 1, andSupplementary Tables S2 and S3).

Stage 2: formal rating of the recommendations (Delphi Round 1)

The list of proposed endpoints and their definitions was sent to all members of the StEP theme subgroup (n¼13) and the StEP Steering Committee (n¼9), using a Delphi questionnaire (Supplementary Table S4). The participants were asked to score each of the items listed using a scale of 1e9, with 1e3 labelled ‘not that important or invalid’, 4e6 labelled ‘impor- tant but requires revision’, and 7e9 labelled ‘critical for in- clusion’.11,12The participants were given the option to select

‘unsure’if they were unable to offer an opinion as to which category to apply to the item. The participants were invited to suggest any other endpoints, or definitions, or modifications to existing definitions that they believed should be added when identifying endpoints in the planning of clinical trials addressing perioperative patient comfort. A reminder e-mail was sent to ensure prompt completion of the survey. The final numbers of respondents and item completions were recorded.

Stage 3: Delphi Round 2

The second Delphi round was coordinated by the StEP theme group Chair (P.M.) and the participants were broadened to include the entire StEP Working Group (n¼89). For each item in the first Delphi round, the number of participants who scored

Ovid MEDLINE 141 studies

102 studies met inclusion criteria EMBASE

47 studies

Web of Knowledge 676 studies

Cochrane database 180 studies

942 excluded on screening tle/abstract/full


122 studies included

20 addional studies found on hand searching

Fig 1.Flow diagram of literature search for systematic reviews of studies of perioperative patient comfort.


the item and the median and inter-quartile range of scores were quantified. Members of the patient-comfort theme group were then invited to discuss the results via e-mail. Any items not rated as critical (i.e. 70th centile score<7), but still with a median score of 7 were retained for consideration in the second round.8 Lower-rated endpoint items identified for removal could be retained if they were considered as critical by any group member for the second round; items with a median score of3 were not retained. Additional endpoints or modi- fied definition items were reviewed by the theme group.

Merging or splitting some endpoints was considered at this time.

A reduced set of items was thus carried forward to Delphi Round 2, using the previous proforma. Quality-of-recovery (QoR) scales were then separately evaluated. The partici- pants were provided with the number (%) of respondents scoring7 for each item in Round 1. They were asked to consider the responses from other Delphi participants, and to re-score the item using a second, modified questionnaire (Supplementary Table S5). A consensus was defined by the support from at least 70% of participants scoring ‘critical’


Stage 4: developing final recommendations and Delphi Round 3

Delphi Round 3 was coordinated by the StEP theme group Chair (P.M.) and the participants were restricted to the au- thors, who were all members of the StEP patient-comfort group (n¼13). The summary results of the aforementioned process were provided to these participants, inviting further comments. If responses to this final stage suggested a need for further modification to endpoint definitions, then this was resolved by the authors via e-mail discussion. Any endpoint items not rated as critical for inclusion (median score7) were not retained for this round. Each endpoint was additionally rated for validitydspecifically, face validity (if this endpoint actually measure the outcome of interest) or content validity (if this endpoint reflect the patient outcome of interest); reli- ability (if the endpoint is reproducible; feasibility (if the endpoint data can be collected by research staff with some training, without undue effort or risk of missing data; and patient centredness [if the endpoint has a meaningful impact on a patient’s recovery (any of discomfort or distress, pro- longed hospital stay, need for re-operation, ongoing disability, or increased risk of death)].

Despite not achieving at least 70% support in the second Delphi round, sleep disturbance was identified as a likely important endpoint by some of the authors, and alternative sleep scales were suggested. These included the Pittsburgh Sleep Quality Index,13the Patient-Reported Outcomes Mea- surement Information System (PROMIS) sleep disturbance item bank,14 and the RichardseCampbell Sleep Questionnaire.15

Each Delphi round was coordinated by the Health Services Research Centre of the Royal College of Anaesthetists in the United Kingdom, or the Research Unit of the Department of Anaesthesia and Perioperative Medicine at the Alfred Hospital in Melbourne, Australia. The item scores and number of re- spondents were recorded for each of the Delphi rounds in an Excel spreadsheet (Microsoft Corporation, Redmond, WA, USA), and then converted to an SPSS (V23.0, SPSS Inc., Chicago, IL, USA) database for calculation of the final median and range scores, and consensus rates.


A long list of potentially relevant patient-comfort outcome measures is presented in Supplementary Table S2. The response rates for Delphi Rounds 1, 2, and 3 were 100% (n¼22), 90% (n¼79), and 100% (n¼13), respectively. The results of the Delphi rounds are presented inTable 1.

Seven of the 22 items nominated in the first Delphi round were removed for the second Delphi round [Item 1 (supple- mentary analgesic use) was retained following a request from one respondent], and another (Opioid-Related Symptom Distress Scale) was on the suggestion of another respondent.

Highly rated patient-comfort outcome measures were carried forward to the second Delphi round (Supplementary Table S5), and the four QoR scales were presented separately. Sixteen of the 23 items nominated in the second Delphi round were removed for the third Delphi round. The supplementary round used to identify the optimal sleep scale resulted in support of the PROMIS sleep disturbance item bank. (Further details are available in Supplementary Table S6.) This resulted in six endpoints, with QoR evaluated with either of two scales (Table 2): (1) postoperative pain intensity at rest and on movement at 24 h, using a numerical rating scale [0e10, with 0¼‘no pain’ and 10¼‘insert maximum endpoint descriptor here (e.g. worst pain possible)’], and reported for pain at 24 h and (ideally) at least one other time point; (2) incidence of postoperative nausea, vomiting/retching, and nausea and vomiting [early (defined as 0e6 h), late (defined as 6e24 h), and overall (use of rescue antiemetic), each reported as number (%)]16; (3) postoperative QoR using either the nine-item QoR score17or the 15-item QoR-15 scale18,19; (4) time to gastroin- testinal recovery, defined by time to tolerate oral diet (e.g. soft food or light meal); and (5) time to mobilisation; and sixth, sleep disturbance, using the PROMIS scale.14


We undertook a systematic review and used a Delphi process to achieve consensus from a broad range of experts involved in perioperative clinical studies. The group identified six stand- ardised endpoints that represent key aspects of patient com- fort in the perioperative setting. We recommend that one or more of these endpoint domains be considered when assess- ing patient comfort in perioperative trials.

There have been previous attempts at identifying outcome measures after surgery, anaesthesia, and critical care.2e4,20 However, we included a broader representation of medical and nursing disciplines, from several countries with differing health systems, and used a Delphi methodology to achieve consensus.5We also considered the validity, reliability, feasi- bility, and patient centredness of these endpoints.6,7 This resulted in a smaller set of endpoints, each with a clear defi- nition and, where available, reference to supporting validation studies. The timing of measurement of any aspect of patient comfort will influence the result, but we have chosen to not stipulate timing for most endpoints because these should be guided by the expected effects of a study intervention.

Clinical researchers do not always measure what is important to patients.21e23Patients value access to clear in- formation; a sense of comfort before, during, and after sur- gery; and a speedy recovery and early return to their own home.17,23,24Several aspects of postoperative pain and com- fort that some readers might consider important were considered, but rejected after the Delphi process, including 708


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opioid consumption and opioid-related side-effects, addi- tional pain intensity scoring, and patient anxiety and well- being. Some components of these are included in the QoR scales, or will manifest as delayed recovery or sleep distur- bance, and so their impact can be evaluated using these tools.

Although this study focused on patient comfort, there are other related aspects of recovery, including well-being, func- tional status, and quality of life. Loss of the ability to live independently is a particular concern for the elderly.25,26 These are being addressed by other StEP groups (see Supplementary Data).1

Patient comfort can be influenced by physical symptoms and distress, or psychological or spiritual concerns. External factors may also play a role, including patients’ physical and social environment, access to care, and healthcare costs.

Patient comfort will be affected by anxiety and other emotional factors, and physical discomforts, such as wound pain, thirst, sore throat, dizziness, headache, constipation, urinary retention, and other symptoms commonly experi- enced after surgery and anaesthesia. Several QoR scales have been developed to encapsulate these outcomes, but few have been extensively validated in a broad range of surgical set- tings. The QoR-40 has been extensively validated and previ- ously recommended,27e31but the QoR score (nine items) and

QoR-15 scales, which have also been externally validated32,33 and are shorter, were recommended by our Delphi process.

Both the QoR score and QoR-15 scales provide patient- centred global assessments of patients’ postoperative recovery.

Our process has some important limitations. For example, we acknowledge that the patients’ experience of comfort should be evaluated from their perspective, and so our de- cision to not include a patient representative in this project deserves scrutiny. However, our purpose was to identify valid and robust endpoints currently used in clinical trials. We, therefore, restricted our analysis to information derived from systematic reviews and meta-analyses in relevant leading journals and to researchers representing anaesthesia, critical care, surgery, and nursing. We fully accept that there are other perspectives that might be of value, and we plan to incorporate patient representatives in future work focused on identifying a core outcome set for perioperative medicine and surgery.1In addition, many of the endpoints that were identified for evaluation in this project had been developed with direct patient involvement.14,17 Interestingly, few au- thors have explicitly reported patient comfort or bothersome pain.34,35 These and other endpoints that were either not considered or discarded during the Delphi process may Table 1Results of the Delphi rounds. ncf, not carried forward; nd, not done; PONV, postoperative nausea and vomiting; PQRS, post- operative quality recovery scale; QoR, quality of recovery

Summary of item* Delphi Round 1 (n¼22) Delphi Round 2 (n¼79) Delphi Round 3 (n¼12) Unsure


Median score


≥7 (%)

Unsure (n)

Median score


≥7 (%) Unsure (n)

Median score


≥7 (%)

1. Supplementary analgesic use 0 6 45 3 5 27 d ncf d

2a. Preoperative anxiety 1 5 38 d ncf d d ncf d

2b. Perioperative anxiety 3 5 37 d ncf d d ncf d

3a. Morphine consumption at 6 h 1 5 33 d ncf d d ncf d

3b. Morphine consumption at 24 h 0 7 68 1 7 54 d ncf d

3c. Morphine consumption at 48 h 0 7 54 2 6 40 d ncf d

4. Subjective analgesic effectiveness 0 7 54 2 6 44 d ncf d

5a. Pain intensity (rest, movement) at 6 h 1 7 81 4 8 78 d ncf d

5b. Pain intensity (rest, movement) at 12 h 0 7 59 1 7 61 d ncf d

5c. Pain intensity (rest, movement) at 24 h 0 8 86 3 8 92 0 9 92

5d. Pain intensity (rest, movement) at 72 h 1 8 76 2 7 68 d ncf d

6. Time to first analgesic request 0 5 41 d ncf d d ncf d

7. Opioid-related side-effects 0 7 68 2 7 68 d ncf d

7a. Opioid-Related Symptom Distress Scale d nd d 4 7 51 d ncf d

8. Incidence of PONV (0e6 h, 6e24 h, and overall) 0 7 64 1 7 87 0 8 92

9. Severity of PONV 0 7 59 4 7 53 d ncf d

10. Incidence of post-discharge nausea, vomiting 0 6 50 2 7 64 d ncf d

11. Severe PONV at 24 h 0 7 59 1 7 58 d ncf d

12. Antiemetic complete response 1 7 52 1 6 29 d ncf d

12. Need for rescue antiemetics 1 6 42 d ncf d d ncf d

13. QoR scales 2 9 90 d d d d d d

QoR score (any of) (any of) 9 8 86 1 8 100

QoR-40 8 7 51 d ncf d

QoR-15 9 8 85 1 8 100

14. QoR (PQRS scale) 6 7 62 11 7 55 d ncf d

15. Time to gastrointestinal recovery 0 7 82 1 7 77 1 8 92

16. Time to mobilisation 0 8 77 1 8 87 0 8 85

17. Shivering 0 4 14 d ncf d d ncf d

18. Perioperative thermal comfort 3 5 21 d ncf d d ncf d

19. Joint arthroplasty range of motion at 24 h 2 6 35 d ncf d d ncf d

20. Fatigue 2 6 40 d ncf d d ncf d

21. Sleep disturbance 2 7 70 4 7 57 1 8 83

22. Adverse events 0 7 54 0 6 39 d ncf d

*SeeMethods sectionand theSupplementary Tablesfor complete definitions.


eventually be found to be valid and patient centred. We encourage such studies and expect to update these StEP recommendations in the future.

In conclusion, we identified six key patient-comfort outcome measures that should be considered by those designing perioperative clinical studies. Standardised end- points will facilitate uniform data reporting, and will support improved benchmarking and meta-analyses of future trials.

Authors’ contributions

Study concept: P.S.M.

Protocol development: P.S.M.

Systematic review and assistance with protocol development:


Participation in the Delphi survey: all authors.

Analysis of the responses: all authors.

First draft and revision of manuscript: P.S.M.

Critical review and revisions of the manuscript: all authors.


The authors thank Ms Laura Farmer and James Goodwin of the National Institute of Academic Anaesthesia, Health Services Research Centre (Royal College of Anaesthetists, London, UK), and Ms Angela Lowe (Alfred Hospital, Melbourne, Australia) for their assistance with the Delphi surveys, and all members of the StEPeCOMPAC Group (listed in the Supplementary Data) who responded in a timely fashion. The authors thank the British Journal of Anaesthesiafor sponsoring a workshop at the Monash University Prato Centre, Italy, in June 2015.

Declaration of interest

P.S.M. is an editor of theBritish Journal of Anaesthesia, and the developer of the quality-of-recovery scales. None of the other authors report any competing interests relating to the topic of this paper.

Appendix A. Supplementary data

Supplementary data related to this article can be found at


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Health Technol Assess2001;5: 1e194 Table2ResultsofthefinalDelphiround:psychometricandclinicalassessments(n¼13).PONV,postoperativenauseaandvomiting;QoR,qualityofrecovery.*Validity¼Doesthe endpointanditsdefinitionhavefacevalidity(inyouropinion,thisendpointactuallymeasurestheoutcomeofinterest)orcontentvalidity(thisendpointreflectsthepatientoutcomeof interest)?yReliability¼Istheendpointreproducible(iftheendpointwascollectedbyothersinsimilarsettings)?zFeasibility¼Cantheendpointdatabecollectedbyresearchstaffwith sometraining,withoutundueeffortorriskofmissingdata?Patientcentredness¼Doestheendpointhaveameaningfulimpactonapatient’srecovery(anyofthefollowing:discomfort ordistress,prolongedhospitalstay,ongoingdisability,orincreasedriskofdeath)? Item*Validity*ReliabilityyFeasibilityPatientcentredness Unsure (n)Median scoreScores ≥7(%)Unsure (n)Median scoreScores ≥7(%)Unsure (n)Median scoreScores ≥7(%)Unsure (n)Median scoreScores ≥7(%) Painintensity(restand movement)at24h09920792091000992 IncidenceofPONV(0e6h, 6e24h,andoverall)2891189209920985 QoRscales QoRscore18100181001810018100 QoR-1518100181001810018100 Timetogastrointestinalrecovery18921783181001892 Timetomobilisation08850885081000892 Sleepdisturbance1875186918751875



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Handling editor: H.C. Hemmings Jr



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